CN116139236B - 一种治疗肝郁型失眠症的中药组合物及其应用 - Google Patents
一种治疗肝郁型失眠症的中药组合物及其应用 Download PDFInfo
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Abstract
本发明提供一种治疗肝郁型失眠症的中药组合物,包括日方和夜方。日方是由以下重量份的原料药制成:柴胡3‑15份、炒白芍12‑24份、煅龙骨20‑40份、砂仁1‑5份、制香附3‑15份、石菖蒲3‑15份、蝉蜕2‑10份、白芷2‑10份、苦参3‑15份、僵蚕3‑15份、川芎3‑15份、甘草2‑10份;夜方是由以下重量份的原料药制成:黄芩3‑15份、肉桂1‑5份、郁金3‑15份、丹参20‑40份、制香附3‑15份、焦山栀3‑15份、首乌藤5‑25份、合欢皮12‑24份、远志3‑15份、灵芝5‑25份、甘草2‑10份。本发明还提供了所述中药组合物的用途。其优点在于:该中药组合物符合君臣佐使的配伍,诸药合用,共奏益神理气,解郁安神之效。
Description
技术领域
本发明涉及中药技术领域,具体地说,是关于一种治疗肝郁型失眠症的中药组合物及其应用。
背景技术
失眠(insomnia)是睡眠障碍的一种表现形式,常表现为难以入睡、维持睡眠困难、过早或者间歇性醒等,可产生一些不适的感觉,比如疲倦、乏力、头痛、情绪不佳及注意力不集中等,影响患者的社会功能。导致失眠的因素有很多,心理因素是主要原因之一,长期的紧张、心理压力过大会影响睡眠。此外,身体疾病、年龄、环境、药物和食物等因素也可导致失眠。一般年龄越大,失眠的发生率越高。
中医认为,失眠的病因病机以七情内伤为主要病因,其涉及的脏腑为心、脾、肝、胆、肾,其病机总属营卫失和,阴阳失调为病之本,或阴虚不能纳阳,或阳盛不得入阴。若情志不舒,思虑过度,影响肝之疏泄,出现肝郁气滞,化火扰神,而耗伤心血,损伤脾运,心肾失交,神志不宁,致使五脏俱虚。根据中医理论,针对失眠的发病机理,进行辩证配伍组方,以达到标本兼治的目的。
目前,对失眠的治疗比较有效、使用最多的药物是镇静催眠药。但是,镇静催眠药存在着副作用,长期服用易出现药物依赖、过度镇静后感知能力下降、脏器受损等。
中国专利文献CN:201110437732.3,公开了一种治疗不寐的中药组合物,它由以下重量份的原料药组成:柴胡5-25份、郁金5-25份、丹参10-30份、百合5-20份、合欢花10-30份、炒枣仁10-40份、龙齿10-40份、夜交藤10-30份、山茱萸5-25份、菟丝子10-30份、生地10-40份、熟地10-40份、山药10-30份、茯神10-30份、栀子5-20份、川断5-25份、肉桂5-20份、黄连3-10份、五味子5-25份、磁石10-40份、黄芩5-20份、龙胆草5-20份。结果证实了该中药组合物治疗不寐疗效显著,作用可靠。
中国专利文献CN:201410746076.9,公开了一种治疗重度失眠的中药组合物,它由以下重量份的原料药组成:珍珠母、龙骨、牡蛎、酸枣仁、藿香、半夏、陈皮、竹茹、黄连、肉桂、白芍、生地、熟地、当归、硫黄菌、川芎、桃仁、红花、绿萼梅、杏仁、石菖蒲、郁金、白豆蔻、厚朴、远志、竹叶、通草、牛角藓、滑石、磁石、斑花杓兰、焦枣仁、百合、合欢皮、高粱、夜交藤、枸杞子、仙灵脾、柏子仁、石斛、白术、党参、黄芪、茯苓、丹参、山栀子、淡豆豉、天竺黄、知母、琥珀、桑椹子、徐长卿、黄芩、鸡子黄、黄连。结果证实了该中药组合物能够安全有效的治疗重度失眠。
诸如此类治疗失眠的中药组合物有很多,但是都有或多或少的缺点,例如,药味过多,取材难,价格昂贵;药效不明显,治疗效果差等等。因此,亟需一种治疗肝郁型失眠效果明显、药味数适中、便于制备的药物。
发明内容
本发明的第一个目的是,针对现有技术中的不足,提供一种治疗肝郁型失眠症的中药组合物。
本发明的再一目的是,提供一种上述药物的用途。
为实现上述第一个目的,本发明采取的技术方案是:
一种治疗肝郁型失眠症的中药组合物,包括日方和夜方。日方由以下重量份的原料药制成:柴胡3-15份、炒白芍12-24份、煅龙骨20-40份、砂仁1-5份、制香附3-15份、石菖蒲3-15份、蝉蜕2-10份、白芷2-10份、苦参3-15份、僵蚕3-15份、川芎3-15份、甘草2-10份;夜方由以下重量份的原料药制成:黄芩3-15份、肉桂1-5份、郁金3-15份、丹参20-40份、制香附3-15份、焦山栀3-15份、首乌藤5-25份、合欢皮12-24份、远志3-15份、灵芝5-25份、甘草2-10份。
优选地,所述的中药组合物日方由以下重量份的原料药制成:柴胡6-12份、炒白芍15-21份、煅龙骨25-35份、砂仁2-4份、制香附6-12份、石菖蒲6-12份、蝉蜕4-8份、白芷4-8份、苦参6-12份、僵蚕6-12份、川芎6-12份、甘草4-8份;夜方由以下重量份的原料药制成:黄芩6-12份、肉桂2-4份、郁金6-12份、丹参25-35份、制香附6-12份、焦山栀6-12份、首乌藤10-20份、合欢皮15-21份、远志6-12份、灵芝10-20份、甘草4-8份。
更优选地,所述的中药组合物日方由以下重量份的原料药制成:柴胡9份、炒白芍18份、煅龙骨30份、砂仁3份、制香附9份、石菖蒲9份、蝉蜕6份、白芷6份、苦参9份、僵蚕9份、川芎9份、甘草6份;夜方由以下重量份的原料药制成:黄芩9份、肉桂3份、郁金9份、丹参30份、制香附9份、焦山栀9份、首乌藤15份、合欢皮18份、远志9份、灵芝15份、甘草6份。
优选地,所述中药组合物的剂型为颗粒剂、片剂、胶囊剂、口服液、合剂或糖浆剂。
为实现上述第二个目的,本发明采取的技术方案是:
如上任一所述的中药组合物在制备治疗失眠药物中的应用。
优选地,所述的失眠为肝郁型失眠症。
药味功效:
柴胡:辛、苦,性微寒。归肝、胆、肺经。和解退热、疏肝解郁、升举阳气。《本草纲目》:“治阳气下陷,平肝胆三焦包络相火”。
炒白芍:性凉,味苦酸,微寒。补血柔肝、平肝止痛。敛阴收汗。《妇人良方》:“微炒。炒焦黄。现行,取白芍片置锅内,用文火加热,炒至表面微黄色,取出放凉。炒用性缓,柔肝,和脾,止泻。”
煅龙骨:性味涩,微寒,入心经、肝经,平肝潜阳、镇静安神、收敛固涩。《名医别录》:“疗心腹烦满,四肢痿枯,汗出,夜卧自惊,恚怒,伏气在心下不得喘息,肠痈内疽,阴蚀,止汗,缩小便,尿血,养精神,定魂魄。安五藏。白龙骨疗梦寐泄精,小便泄精。”
砂仁:味辛,性温。归脾、胃、肾经。芳香行散,降中有升。化湿开胃、温脾止泻、理气安胎。《本草经疏》:“味辛,气温,无毒;入足太阴、阳明、少男、厥阴、亦入手太阴,阳明、厥阴。可升可降,降多于升,阳业。”
制香附:辛、微苦、微甘,平。归肝、脾、三焦经。疏肝解郁,理气宽中,调经止痛。《纲目》:“香附之气平而不寒,香而能窜,其味多辛能散,微苦能降,微甘能和。”
石菖蒲:温,辛、苦。归心、胃经。化湿开胃,开窍豁痰,醒神益智。《本草纲目》:“菖蒲气温,心气不足者用之,虚则补其母也。肝苦急,以辛补之是矣。”
蝉蜕:味甘、咸,性凉。归肺、肝经。疏散风热,利咽开音,透疹,明目退翳,息风止痉。《本草纲目》:“蝉,主疗皆一切风热证,古人用身,后人用蜕,大抵治脏府经络,当用蝉身;治皮肤疮疡风热,当用蝉蜕。”
白芷:性温,味辛,气芳香,微苦。归肺,脾,胃经。解表散寒,祛风止痛,通鼻窍,燥湿止带,消肿排脓,祛风止痒。《本草经解》:“入足厥阴肝经、足阳明胃经、手阳明大肠经。”
苦参:味苦,性寒。归心、肝、胃、大肠、膀胱经。清热燥湿,杀虫,利尿。《千金方》:“热病狂邪,不避水火,欲杀人:苦参末,蜜丸梧子大每服十丸,薄荷汤下。亦可为末,二钱,水煎服。”
僵蚕:味咸、辛,性平。归肝、肺、胃经。息风止痉,祛风止痛,化痰散结。《百一选方》:“治头风:白僵蚕(去丝、嘴)、良姜等分。为细末。每服半钱,白梅茶清调下,临发时服。”
川芎:味辛,温。归肝、胆经。行气活血止痛,助柴胡以解肝经之郁滞,增其行气止痛之功;《日华子本草》:“治一切风,一切气,一切劳损,一切血,补五劳,壮筋骨,调众脉,破症结宿血,养新血,长肉,鼻洪,吐血及溺血,痔瘘,脑痈发背,瘰疬瘿赘,疮疥,及排脓消瘀血。”
黄芩:味苦,性寒。归肺、胆、脾、大肠、小肠经。清热燥湿,泻火解毒,止血,安胎。《本草纲目》:“治风热湿热头疼,奔豚热痛,火咳肺痿喉腥,诸失血。”
肉桂:味辛、甘,性大热。归肾、脾、心、肝经。镇静镇痛、降温、抗菌、通经。《本经逢原》:“郁金辛香不烈,先升后降,入心及包络。治吐血、衄血、唾血血腥,破恶血。血淋,尿血,妇人经脉逆行,产后败血冲心,及宿血心痛,并宜郁金末加姜汁、童便同服,其血自清。”
郁金:辛、苦,寒。归肝、心、肺经。活血止痛,行气解郁,清心凉血,利胆退黄。《本经逢原》:“郁金辛香不烈,先升后降,入心及包络。治吐血、衄血、唾血血腥,破恶血。血淋,尿血,妇人经脉逆行,产后败血冲心,及宿血心痛,并宜郁金末加姜汁、童便同服,其血自清。”
丹参:味苦,微寒。归心、肝经。活血祛瘀,通经止痛,清心除烦,凉血消痈。《本草纲目》:“活血,通心包络,治疝痛。”
焦山栀:取碾碎的栀子,置锅内用武火炒至焦糊色,取出,放凉。味苦,寒。归心、肺、三焦经。泻火除烦,清热利湿,凉血解毒;外用消肿止痛。《本草衍义》:“仲景治(伤寒)发汗吐下后,虚烦不得眠;若剧者,必反复颠倒,心中懊憹,栀子豉汤治之。虚故不用大黄,有寒毒故也。栀子虽寒无毒,治胃中热气,既亡血、亡津液,腑脏无润养,内生虚热,非此物不可去。又治心经留热,小便亦涩,用去皮山栀子、火煨大黄、连翘、甘草(炙),等分,末之,水煎三钱服,无不利也。”
首乌藤:味甘、微苦,性平。归心、肝经。养心安神,祛风,通络。《本草再新》:“补中气,行经络,通血脉,治劳伤。”
合欢皮:甘;平。入心、肝经。解郁、和血、宁心、消痈肿。《本经》:“主安五脏,和心志,令人欢乐无忧。”
远志:苦、辛、温。归心、肾、肺经。安神益智、祛痰、消肿。《本草再新》云:“行气散郁,并善豁痰。”
灵芝:味甘,性平;归心、肺、肝、肾经。补气安神,止咳平喘。《神农本草经》:“紫芝味甘温,主耳聋,利关节,保神益精,坚筋骨,好颜色,久服轻身不老延年。”
甘草:味甘,性平。归心、肺、脾、胃经。补脾益气,清热解毒,祛痰止咳,缓急止痛,调和诸药。《日华子本草》:“安魂定魂,补五劳七伤,一切虚损,惊悸烦闷、健忘,通九窍,利百脉,益精养气,壮筋骨,解冷热。入药久用。
本发明优点在于:
1.日方以柴胡、白芍为君,柴胡发表退热,疏肝解郁,白芍主要功效是柔肝止痛,养血敛汗;香附、菖蒲活血行气,散滞解郁,为臣药;“脑为清阳之府”,白芷、川芎升清阳,调气血,使气血调畅,脑神自安。蝉蜕、僵蚕解郁息风,甘草、苦参安神除烦;柴胡合龙骨疏降相合,理气疏肝,潜阳安神,为佐药;“五脏皆有不寐”,香附合砂仁疏肝行气,理气和胃,使胃和则卧安,为使药。诸药合用,全方共奏益神理气,解郁安神之效。
2.夜方黄芩配肉桂辛甘,性温,为君药。入肾、脾、心、肝经。可温中补阳,祛寒止痛。黄芩、肉桂为伴,可使水火既济,阳阴交泰。黄芩善净心热,泻内火;肉桂粉善于和心力,还可温肾水,使以上济于心,并能引火归元。二药为伴,热寒并用,有上泻内火,下温肾水,交通心肾之妙,治心肾不交之失眠。栀子清三焦之浮火,合欢皮解郁安神,使人愉悦,首乌藤养心安神,合欢皮安神解郁,合欢皮和首乌藤配伍,药效可以互补,为臣药。丹参活血祛瘀,归心肝经,主入血分,功善活血化瘀,去瘀生新,郁金、香附行气解郁,远志、灵芝开窍安神,为佐药。甘草有补脾益气,调和诸药的功效,为使药。全方共奏安眠益肾,解郁清心之效。
3.睡眠和觉醒是一个整体,人体在一个个睡眠—觉醒周期交替中生活。中医古籍《黄帝内经·营卫生会》云“壮者之气血盛,其肌肉滑,气道通,营卫之行不失其常,故昼精而夜瞑。”又云:“老者之气血衰,其肌肉枯,气道涩,五藏之气相搏,其营气衰少而虚阳内伐,故昼不精,夜不瞑。”意思是青壮年的气血旺盛,肌肉壮实,气道畅通,营卫的运行都很正常,所以白天的精神饱满,而晚上睡得很熟。而老年人脏腑、气血功能衰退,白天的生活精力和夜间的睡眠均存在质量的减退。现代社会因为工作、学习、生活等压力,生活节奏的变化,导致“昼不精,夜不瞑”的人群趋于年轻化,睡眠觉醒机制产生紊乱导致失眠。而有关失眠的治疗往往关注了延长夜间睡眠时间,而忽视了对白天功能损害的改善。日方加入白芷、菖蒲等药物,白芷辛温气厚,石菖蒲辛开苦降,此类药物辛散芳香,醒神开窍而引阴阳外出,振奋阳气,调整白天的精神状态,使体力、思维、精力、情绪得到改善;睡前服用夜方针对“夜不瞑”加用首乌藤等,或用交泰丸,可纳阳入阴,促进良好的睡眠状态。
具体实施方式
下面结合具体实施方式,进一步阐述本发明。应理解,这些实施例仅用于说明本发明而不用于限制本发明的范围。此外应理解,在阅读了本发明记载的内容之后,本领域技术人员可以对本发明作各种改动或修改,这些等价形式同样落于本申请所附权利要求书所限定的范围。
实施例1治疗肝郁型失眠症的中药组合物(一)
日方:柴胡9份、炒白芍18份、煅龙骨30份、砂仁3份、制香附9份、石菖蒲9份、蝉蜕6份、白芷6份、苦参9份、僵蚕9份、川芎9份、甘草6份;夜方:黄芩9份、肉桂3份、郁金9份、丹参30份、制香附9份、焦山栀9份、首乌藤15份、合欢皮18份、远志9份、灵芝15份、甘草6份。制成颗粒剂服用。
实施例2治疗肝郁型失眠症的中药组合物(二)
日方:柴胡9份、炒白芍15份、煅龙骨35份、砂仁1份、制香附15份、石菖蒲9份、蝉蜕4份、白芷8份、苦参3份、僵蚕15份、川芎9份、甘草4份;夜方:黄芩9份、肉桂2份、郁金12份、丹参20份、制香附15份、焦山栀9份、首乌藤10份、合欢皮21份、远志3份、灵芝25份、甘草6份。制成颗粒剂服用。
实施例3治疗肝郁型失眠症的中药组合物(三)
日方:柴胡6份、炒白芍21份、煅龙骨20份、砂仁5份、制香附9份、石菖蒲6份、蝉蜕8份、白芷2份、苦参15份、僵蚕9份、川芎6份、甘草8份;夜方:黄芩6份、肉桂4份、郁金3份、丹参40份、制香附9份、焦山栀6份、首乌藤20份、合欢皮12份、远志15份、灵芝15份、甘草4份。制成颗粒剂服用。
实施例4治疗肝郁型失眠症的中药组合物(四)
日方:柴胡12份、炒白芍12份、煅龙骨40份、砂仁3份、制香附6份、石菖蒲12份、蝉蜕2份、白芷10份、苦参9份、僵蚕6份、川芎12份、甘草2份;夜方:黄芩12份、肉桂1份、郁金15份、丹参30份、制香附6份、焦山栀12份、首乌藤5份、合欢皮24份、远志9份、灵芝10份、甘草8份。制成颗粒剂服用。
实施例5治疗肝郁型失眠症的中药组合物(五)
日方:柴胡3份、炒白芍24份、煅龙骨30份、砂仁2份、制香附12份、石菖蒲3份、蝉蜕10份、白芷6份、苦参6份、僵蚕12份、川芎3份、甘草10份;夜方:黄芩3份、肉桂5份、郁金9份、丹参25份、制香附12份、焦山栀3份、首乌藤25份、合欢皮18份、远志6份、灵芝20份、甘草2份。制成颗粒剂服用。
实施例6治疗肝郁型失眠症的中药组合物(六)
日方:柴胡15份、炒白芍18份、煅龙骨25份、砂仁4份、制香附3份、石菖蒲15份、蝉蜕6份、白芷4份、苦参12份、僵蚕3份、川芎15份、甘草6份;夜方:黄芩15份、肉桂3份、郁金6份、丹参35份、制香附3份、焦山栀15份、首乌藤15份、合欢皮15份、远志12份、灵芝5份、甘草10份。制成颗粒剂服用。
实施例7治疗肝郁型失眠症的中药组合物(七)
日方:柴胡9份、炒白芍21份、煅龙骨20份、砂仁5份、制香附9份、石菖蒲6份、蝉蜕8份、白芷2份、苦参15份、僵蚕9份、川芎6份、甘草8份;夜方:黄芩9份、肉桂4份、郁金3份、丹参40份、制香附9份、焦山栀6份、首乌藤20份、合欢皮12份、远志15份、灵芝15份、甘草4份。制成颗粒剂服用。
实施例8治疗肝郁型失眠症的中药组合物(八)
日方:柴胡6份、炒白芍12份、煅龙骨40份、砂仁3份、制香附6份、石菖蒲12份、蝉蜕2份、白芷10份、苦参9份、僵蚕6份、川芎12份、甘草2份;夜方:黄芩6份、肉桂1份、郁金15份、丹参30份、制香附6份、焦山栀12份、首乌藤5份、合欢皮24份、远志9份、灵芝10份、甘草8份。制成颗粒剂服用。
实施例9治疗肝郁型失眠症的中药组合物(九)
日方:柴胡12份、炒白芍24份、煅龙骨30份、砂仁2份、制香附12份、石菖蒲3份、蝉蜕10份、白芷6份、苦参6份、僵蚕12份、川芎3份、甘草10份;夜方:黄芩12份、肉桂5份、郁金9份、丹参25份、制香附12份、焦山栀3份、首乌藤25份、合欢皮18份、远志6份、灵芝20份、甘草2份。制成颗粒剂服用。
实施例10治疗肝郁型失眠症的中药组合物(十)
日方:柴胡3份、炒白芍18份、煅龙骨25份、砂仁4份、制香附3份、石菖蒲15份、蝉蜕6份、白芷4份、苦参12份、僵蚕3份、川芎15份、甘草6份;夜方:黄芩3份、肉桂3份、郁金6份、丹参35份、制香附3份、焦山栀15份、首乌藤15份、合欢皮15份、远志12份、灵芝5份、甘草10份。制成颗粒剂服用。
实施例11治疗肝郁型失眠症的中药组合物(十一)
日方:柴胡15份、炒白芍15份、煅龙骨35份、砂仁1份、制香附15份、石菖蒲9份、蝉蜕4份、白芷8份、苦参3份、僵蚕15份、川芎9份、甘草4份;夜方:黄芩15份、肉桂2份、郁金12份、丹参20份、制香附15份、焦山栀9份、首乌藤10份、合欢皮21份、远志3份、灵芝25份、甘草6份。制成颗粒剂服用。
实施例12治疗肝郁型失眠症药物颗粒的制备
取实施例1-11任一所述的药物,加8-10倍量水,煎煮3小时,滤出药汁。再加10倍量水,煎煮2.5小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液2倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加适当制药辅料,制粒,干燥,整粒,得20g颗粒,分装10g/袋。
实施例13治疗肝郁型失眠症药物片剂/胶囊的制备
取实施例1-11任一所述的药物,加9-11倍量水,煎煮2-3.5小时,滤出药汁。再加9倍量水,煎煮2.5小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液3倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加入制药辅料,真空干燥,粉碎制粒,压制成片剂或填充装胶囊。
实施例14治疗肝郁型失眠症药物合剂/口服液/糖浆剂的制备
取实施例1-11任一所述的药物,加8-11倍量水,煎煮3小时,滤出药汁。再加8倍量水,煎煮3小时,滤出药汁,合并二次煎液,静置,滤取上清液,浓缩,放冷,加浓缩液3.5倍量酒精,搅拌沉淀过夜。取上清液,浓缩至稠浸膏;加适当制药辅料,制成合剂、口服液或糖浆剂
实施例15临床实验
目的:观察安眠益神双剂颗粒治疗肝郁型失眠症患者自身前后的疗效。
1.患者资料
静安区中医医院及大宁路街道社区卫生服务中心的门诊患者,通过相关量表评估符合诊断标准及纳入标准,受试者了解并自愿参加此次试验,并签署知情同意书,能够定期复诊,观察时间为4周,拟纳入60例。
2.病证参照:
定义:有入睡困难,持续睡眠障碍或睡眠后没有恢复感,每周3次并持续至少1个月,导致明显的不适或影响了日常生活,非神经系统疾病、使用精神药物或其他药物等因素引起的睡眠障碍,通常指患者对睡眠时间和(或)质量不满足,并影响白天社会功能的一种主观体验。
表现形式:
(1)睡眠潜伏期延长:入睡时间超过30min;
(2)睡眠维持障碍:夜间觉醒次数≥2次或凌晨早醒;
(3)睡眠质量下降:睡眠浅、多梦;
(4)总睡眠时间缩短:通常少于6h;
(5)日间残留效应:次晨感到头昏、精神不振、嗜睡、乏力等。
3.标准
3.1中医诊断标准:
(1)2004年《上海市中医失眠症专科临床诊疗方案》(辨证):主症:情志不悦,入夜难寐,心烦郁闷,眼眶晦暗,舌质紫暗;次症:两胁胀痛,寡言少语,眶下色斑,舌质瘀点,脉弦微涩;
(2)2008年《中医内科常见病诊疗指南中医病证部分》(辨病):入睡困难,或睡而易醒,醒后不能再睡,重则彻夜难眠,连续4周以上;常伴有多梦、心烦、头昏头痛、心悸健忘、神疲乏力等症状;无妨碍睡眠的其他器质性病变和诱因;
(3)2009年《失眠症中医诊疗指南》上海市行业标准:以失眠为主症及其相关躯体疾病和其他精神疾病、多脏腑加杂症和五脏皆有不寐的特点,主要分8个常见证型:肝阳上亢、肝亢犯肺、肝亢肾虚、肝亢脾虚、肝郁化火(化风)、肝郁瘀阻、肝郁犯胃(或横逆)、肝郁犯心。
3.2西医诊断标准:(CCMD-3)诊断至少应包括以下第1-3项:
(1)主诉失眠;
(2)几乎每天使用催眠药物,至少持续三周;
(3)催眠药撤除后,睡眠问题再现,并比用药之前更严重;
(4)撤药期间,白天出现恶心、肌紧张、疼痛、不安和情绪紧张;
(5)多导睡眠图可见下列表现中任何一种:①使用催眠药物期间,睡眠结构可正常;②撤药时,睡眠潜伏期延长,总的睡眠时间和睡眠效率下降,伴NREM睡眠第3、4期和REM睡眠时间缩短,而NREM睡眠第1、2期时间延长;
(6)无其他可解释睡眠障碍的精神或躯体疾病;
(7)可并存其他类型的睡眠障碍,但不能用其解释原反征状。
3.3纳入标准
(1)符合ICD-10中失眠的诊断标准;
(2)中医辨证结合失眠症中医症候量表评估符合肝郁类不寐病;
(3)改进型SPIEGEL量表检测评分≥12分(失眠程度以12分为基线,≥12分为失眠症,≥18分为中度失眠症,≥24分为重度失眠症。);
(4)为18至80岁门诊患者,知情、同意接受随访观察;
(5)平素仅偶尔服用安眠药,近2周未服用任何安眠类及精神类药物;
(6)神志清楚,生命体征平稳,具有一定的表达能力与执行能力,能配合完成测试及治疗。
3.4排除标准
(1)不符合纳入标准者,排除严重的继发失眠者;
(2)汉密尔顿焦虑量表(HAMA)总分≥14分;
(3)密尔顿抑郁量表(HAMD,17项)总分≥18分;
(4)需要长期规律服用2种及以上具有治疗失眠功效的中西药者;
(5)需要长期服用除原催眠药外其他具有精神活性类的药品者;
(6)合并有心血管、肺、肝、肾、或造血系统、内分泌系统等严重疾病,精神疾患、脑器质性疾病及药物滥用或视力、听力明显障碍者;
(7)妊娠或哺乳期妇女;
(8)酗酒或药物依赖者;
(9)对本方案实验用药或所含成分过敏者;
(10)无法完成实验者或研究者认为其他原因不能入选者。
3.5终止标准
(1)用药期间发生严重不良反应或其他意外事件,不宜继续接受试验者;
(2)试验期间患者不愿继续接受试验者;
(3)试验期间患者病情恶化,需要采取其他治疗措施。
4.治疗方法
中药:安眠益神双剂颗粒(四川新绿药业公司生产;免煎颗粒包装)。用法:每日早饭后服用益神剂(柴胡9g、炒白芍18g、煅龙骨(先煎)30g、砂仁(后下)3g、制香附9g、石菖蒲9g、蝉蜕6g、白芷6g、苦参9g、僵蚕9g、川芎9g、甘草6g),温水冲服200ml;晚饭后服用安眠剂(黄芩9g、肉桂(后下)3g、郁金9g、丹参30g、制香附9g、焦山栀9g、首乌藤15g、合欢皮18g、炙远志9g、灵芝15g、甘草6g),温水冲服200ml。(汤剂则要遵循先煎后下的原则)
5.临床研究方法
本研究通过对患者治疗前后采用匹兹堡睡眠质量指数问卷(PSQI)、汉密尔顿焦虑抑郁量表来评估精神状态、睡眠状况、中医症状总积分,较全面分析本药物临床疗效。
5.1观察时间
共观察4周,每2周随访一次(第2周末、第4周末)。
5.2安全性观察指标
(1)一般生命体征:心率、呼吸、血压、体温。
(2)有无药物副反应:头晕头痛、恶心呕吐、胸闷心慌、食欲减退、皮疹、腹泻、便秘等。
(3)生化指标:肝、肾功能(入组初期及治疗28天后)。
5.3临床疗效评估方法
5.3.1临床研究量表评估内容
(1)PQSI比较;
(2)PSQI分项评分比较;
(3)焦虑、抑郁量表比较;
(4)中医症状总积分;
(5)治疗前后临床疗效比较。
5.3.2疗效评判标准:
(1)2002年国家卫生部《中药新药临床研究指导原则》的疾病疗效评判标准,采用尼莫地平减分率方法作出疗效评价,根据(治疗前评分-治疗后评分)/治疗前评分×100%得出四个等级:
①临床痊愈:睡眠时间回复正常或夜间睡眠时间增加至6小时以上,睡眠深沉,醒后精神充沛。评分减少≥75%;
②显效:睡眠明显好转,睡眠时间增加3小时以上,睡眠深度增加。评分减少≥50%;
③有效:症状减轻,睡眠时间较前增加不足3小时,评分减少≥25%;
④无效:治疗后失眠无明显改善或反加重者,评分减少<25%。
总有效=痊愈+显效+有效。
疗效评价指标:匹兹堡睡眠质量指数问卷(PSQI)、焦虑、抑郁量表。
(2)中医证候疗效判定标准:
2002年国家卫生部《中药新药临床研究指导原则》结合1994年国家中医药管理局《中医病证诊断疗效标准》:
中医症状总积分减分率=(治疗前中医症状总积分-治疗后中医症状总积分)/治疗前中医症状总积分×100%同样得出四个等级:
①痊愈:症状、体征消失或基本消失,中医症状总积分减分率≥95%;
②显效:症状、体征明显改善,中医症状总积分减分率≥70%;
③进步:症状、体征均有好转,中医症状总积分减分率≥30%;
④无效:症状、体征无明显改善,甚或加重,中医症状总积分减分率<30%。
总有效=痊愈+显效+进步。(疗效评价指标:中医症候积分量表)
6.结果
6.1治疗前后PQSI比较
与治疗前相比,治疗后患者的PSQI评分明显下降,P<0.05,有统计学意义(见表1)。
表1PSQI评分及分项比较
注:与治疗前相比,*P<0.05。
6.2治疗前后PSQI分项评分比较
与治疗前相比,治疗后患者的PSQI分项评分:睡眠质量、入睡时间、睡眠时间、睡眠效率、日间功能均呈现下降趋势,P<0.05,具有统计学意义(见表2)。
表2PSQI分项评分比较
注:与治疗前相比,*P<0.05
6.3治疗前后焦虑、抑郁量表比较
与治疗前相比,患者的汉密尔顿焦虑、抑郁量表评分指数均有显著下降,P<0.01,具有统计学意义(见表3)。
表3治疗前后焦虑、抑郁量表比较(N=60)
注:与治疗前相比,*P<0.01
6.4治疗前后中医症候积分比较
中医症候积分在第2周末治疗后评分与治疗前比较有统计学意义(P<0.05),在第4周末治疗前后评分比较有明显统计学意义(P<0.01),见表4。
表4患者治疗前后中医症候积分比较(分)
注:与本组治疗前比较,*P<0.05,**P<0.01。
6.5治疗前后临床疗效比较
60位患者中,有16位患者(26.67%)睡眠时间恢复正常,达到临床痊愈;25位患者(41.67%)表示睡眠明显好转,为显效;13位患者(21.67%)症状减轻,睡眠时间有所增加,为有效,总有效率为90.00%(见表5)。
表5失眠患者治疗后的临床疗效(n=60)
实施例13动物实验
1.材料与方法
1.1实验材料
1.1.1实验动物
SPF级大鼠48只,体质量(200±20)g,由上海斯莱克实验动物有限公司提供饲养于恒温(20±3)℃和12:12固定照明节律的环境下,并可自由摄取食物和水。
1.1.2实验药物
本发明一:日方(柴胡9份、炒白芍18份、煅龙骨30份、砂仁3份、制香附9份、石菖蒲9份、蝉蜕6份、白芷6份、苦参9份、僵蚕9份、川芎9份、甘草6份);夜方(黄芩9份、肉桂3份、郁金9份、丹参30份、制香附9份、焦山栀9份、首乌藤15份、合欢皮18份、远志9份、灵芝15份、甘草6份);
本发明组二:日方:柴胡3份、炒白芍24份、煅龙骨30份、砂仁2份、制香附12份、石菖蒲3份、蝉蜕10份、白芷6份、苦参6份、僵蚕12份、川芎3份、甘草10份;夜方:黄芩3份、肉桂5份、郁金9份、丹参25份、制香附12份、焦山栀3份、首乌藤25份、合欢皮18份、远志6份、灵芝20份、甘草2份;
对照组:日方(柴胡9份、炒白芍18份、煅龙骨30份、砂仁3份、制香附9份、石菖蒲9份、牛蒡子6份、白芷6份、黄芩9份、僵蚕9份、川芎9份、甘草6份);夜方(黄芩9份、肉桂3份、郁金9份、牛膝30份、制香附9份、焦山栀9份、首乌藤15份、莲子心18份、远志9份、灵芝15份、甘草6份);
西药组:阿普唑仑(上海市静安区中医医院提供);
空白组:生理盐水;
模型组:生理盐水。
1.1.3试剂及仪器
5-羟色胺(5-HT)酶联免疫检测试剂盒(上海森雄生物科技有限公司);全自动血流变测试仪(资产编号:ZY2016000046,型号:SA-6900,赛科希德);全自动凝血分析仪(资产编号:ZY201904000006,型号:CS-2000i,sysmex);Morris水迷宫视频跟踪系统。
1.2实验方法
1.2.1分组
48只大鼠依据随机数字表法分为:治疗组一、治疗组二、对照组、西药组、空白组、模型组,每组8只。
1.2.2肝郁失眠大鼠模型的建立
采用该领域被广泛认可的大鼠慢性夹尾刺激和PCPA腹腔注射复合制造肝郁失眠大鼠模型。除空白组外,其余各组动物先采用夹尾刺激法致肝郁:即将大鼠每笼5只喂养,用尖端包裹纱布的大弯止血钳,夹住其中1只大鼠的尾巴,令其与笼中其他大鼠撕打,从而激怒全笼大鼠,令全笼大鼠处于对峙状态,每次刺激20min,1次/天,连续刺激1周,使大鼠感到郁怒不适而不得发,见情绪抑郁、胡须下垂、叫声尖细,即符合肝郁表现。
将PCPA溶于弱碱性生理盐水中,配置成混悬液,以250mg/(kg·只)对大鼠进行腹腔注射,1次/d,连续2d,观察发现大鼠昼夜节律消失,白天夜晚活动不停,睡眠减少直至消失,进食及饮水增多,体毛凌乱无华,精神萎靡,再次刺激时,反抗明显减弱,整体观察与正常动物明显不同,表明造模成功。
1.2.3给药方法
治疗组一用本发明中药组合物一制备的颗粒剂7.5g/kg/d灌胃,治疗组二用本发明中药组合物二制备的颗粒剂7.5g/kg/d灌胃,对照组用对照组制备的颗粒剂7.5g/kg/d灌胃,西药组用阿普唑仑片剂10mg/kg/d灌胃,连续21d。
1.3观察检测指标
(1)观察大鼠治疗前后精神、活动、睡眠、排泄等状态。
(2)血液流变学分析:大鼠腹主动脉取血,测定血浆黏度。
(3)下丘脑、海马组织5-HT含量的测定:麻醉大鼠迅速在冰上取脑,分离双侧海马和下丘脑,采用酶联免疫吸附法(ELISA)测定大鼠下丘脑、海马组织5-HT的含量,具体操作参照试剂盒说明书。
1.4统计学方法
统计学方法计数资料及等级资料组间比较采用Fisher精确检验;计量资料x±s以表示,多组间比较采用单因素方差分析(方差非齐性者采用Tam hanesT检验)。应用GraphPad Prism 8软件作统计分析,P<0.05为有统计学意义。
2结果
2.1体征比较
用药前造模大鼠均表现为睡眠节律消失,精神萎靡但极易受惊,对激惹常呈逃避状态,贴边弓背活动或扎堆蛰伏在角落,进食明显减少,大便较稀;毛发散乱枯燥、胡须下垂、眼角有分泌物。用药三周后,较模型组相比,治疗组大鼠对峙、撕咬的情况较少,搔爪、洗脸、舔足、理毛等动作基本灵活,毛发整洁、饮食正常,大鼠睡眠节律正常;对照组大鼠精神状态稍弱,叫声比较柔和,大便形状有时不规则,饮食饮水增加;西药组饮食饮水增加,精神状态良好,睡眠节律基本存在。
2.2各组大鼠血流变学指标比较
与空白组比较,模型组大鼠的高、中、低切全血黏度均升高(P<0.05);与模型组比较,治疗组、对照组大鼠的全血黏度下降(P<0.05);与对照组、西药组比较,治疗组的全血黏度下降(P<0.05)(见表6)。
表6各组大鼠血流变学指标比较
注:与空白组比较1)(P<0.05);与模型组比较2)(P<0.05);与对照组比较3)(P<0.05);西药组比较4)(P<0.05)。
2.3各组大鼠下丘脑、海马组织5-HT含量比较
与空白组比较,模型组大鼠下丘脑、海马的5-HT含量明显降低(P<0.01);与模型组相比,治疗组、对照组、西药组下丘脑、海马区的5-HT含量升高(P<0.05);治疗组大鼠与对照组、西药组相比,下丘脑、海马区的5-HT含量升高(P<0.05)(见表7)。
表7各组大鼠下丘脑、海马组织5-HT含量比较
注:与空白组比较1)(P<0.01);与模型组比较2)(P<0.05);与对照组比较3)(P<0.05);与西药组比较4)(P<0.05)。
以上所述仅是本发明的优选实施方式,应当指出,对于本技术领域的普通技术人员,在不脱离本发明方法的前提下,还可以做出若干改进和补充,这些改进和补充也应视为本发明的保护范围。
Claims (4)
1.一种治疗失眠症的中药组合物,其特征在于,包括日方和夜方,日方由以下重量份的原料药制成:柴胡6-12份、炒白芍15-21份、煅龙骨25-35份、砂仁2-4份、制香附6-12份、石菖蒲6-12份、蝉蜕4-8份、白芷4-8份、苦参6-12份、僵蚕6-12份、川芎6-12份、甘草4-8份;夜方由以下重量份的原料药制成:黄芩6-12份、肉桂2-4份、郁金6-12份、丹参25-35份、制香附6-12份、焦山栀6-12份、首乌藤10-20份、合欢皮15-21份、远志6-12份、灵芝10-20份、甘草4-8份。
2.根据权利要求1所述的中药组合物,其特征在于,日方由以下重量份的原料药制成:柴胡9份、炒白芍18份、煅龙骨30份、砂仁3份、制香附9份、石菖蒲9份、蝉蜕6份、白芷6份、苦参9份、僵蚕9份、川芎9份、甘草6份;夜方由以下重量份的原料药制成:黄芩9份、肉桂3份、郁金9份、丹参30份、制香附9份、焦山栀9份、首乌藤15份、合欢皮18份、远志9份、灵芝15份、甘草6份。
3.根据权利要求1或2所述的中药组合物,其特征在于,所述中药组合物的剂型是颗粒剂、片剂、胶囊剂、口服液、合剂或糖浆剂。
4.根据权利要求1或2所述的中药组合物在制备治疗失眠药物中的应用,所述的失眠为肝郁型失眠症。
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